Eptinezumab With Patient Education for Chronic Migraine and Medication-Overuse Headache: The Randomized, Placebo-Controlled RESOLUTION Trial
Abstract
Background and objectives: Medication-overuse headache (MOH) commonly co-occurs with and complicates chronic migraine (CM). This trial evaluated efficacy and safety of eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention-combined with a standardized brief educational intervention (BEI)-in adults with CM and MOH. We report results from the 12-week placebo-controlled period, of which weeks 1-4 was the primary time point.
Methods: The phase 4, double-blind, placebo-controlled RESOLUTION trial was conducted at 76 specialist clinics across 11 countries. Eligible participants were adults diagnosed with CM and MOH and were randomized 1:1 to eptinezumab 100 mg IV with BEI or placebo IV with BEI. The primary end point was mean change from baseline in monthly migraine days (MMDs; weeks 1-4). Key secondary end points (multiplicity-controlled) included changes from baseline in monthly headache days, monthly days with acute migraine medication use, and average daily pain, as well as fulfillment of thresholds defining CM and MOH. Treatment-emergent adverse events (TEAEs) were assessed.
Results: Between July 2022 and March 2025, 608 participants were randomized, and 596 (98%) completed the placebo-controlled period. Of 604 participants treated, 517 (86%) were female and 87 (14%) were male; the mean age was 45.5 years (SD 12.0). The primary end point, mean change from baseline in MMDs (weeks 1-4), favored eptinezumab with BEI vs placebo with BEI…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 604 participants or records.
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